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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K052777
Device Name LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D
Applicant
Ellex Medical Pty. Ltd.
82 GILBERT ST.
ADELAIDE, SOUTH AUSTRALIA,  AU 5000
Applicant Contact KEVIN HOWARD
Correspondent
Ellex Medical Pty. Ltd.
82 GILBERT ST.
ADELAIDE, SOUTH AUSTRALIA,  AU 5000
Correspondent Contact KEVIN HOWARD
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HQF  
Date Received10/03/2005
Decision Date 03/16/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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